There is most certainly an ethical component(or lack there of) when it comes to releasing medical devices or anything consumers could sustain harm from without proper testing. There is a reason why there are established statutes in place that allow…   Read more»

All of the components associated with design controls serve a necessary purpose. However, the design verification process and design validation processes are the most important. Both the verification and validation procedures, in addition, to the DID and DSD, allow companies…   Read more»

The underlying purpose of the DSD and DID is to ensure the customer’s needs are satisfied. To develop a product effectively, the company must meet the overall perspective of the product and the detailed functions as well. The DSD ensures…   Read more»

The verification process is crucial for several reasons. For one, if customers are the first to identify the flaw(s) in a product, that diminishes the company’s credibility. It also demonstrates the company’s attention to detail. One way to improve the…   Read more»

When I interned with the Navy, a large portion of my time was spent in classes teaching different teams how to implement Scrum or different agile thinking methods to improve productivity. To prioritize the way that tasks were sequenced in…   Read more»

When I like to tackle a challenge, I find it very helpful to alter one variable at a time. In this simulation, by changing the packaging and medicine at one time, a concrete solution could not be determined if this…   Read more»

I would first hold a team meeting, as many others before me have said. At this meeting, I would ask questions that pertain to goals or tasks the previous project manager has put into place. This will generally give me…   Read more»

I agree with all posts here, that communication would be a very large part of getting the team back on track. In addition, I agree with @ridmehta, in having a sit-down meeting with each team member individually. I would want…   Read more»

As I  am going through this course and gaining more knowledge on medical devices and the process which it takes for them to reach the market I realize it goes back to the basics. As a scientist, the scientific method…   Read more»

There are nine components that make up design controls that build from one to the other. Knowing the goal of medical device development and meeting that goal is the outcome of the design controls. I believe the planning aspect is…   Read more»

According to the lecture, there is a difference between verification and validation in most cases. However, sometimes the verification is interchangeable with validation. If the product that you are producing is verified and the input equals the output all specs…   Read more»

I’m one of those people who believes that anything is possible, it boils down to how much work one wants to put in to achieve possible. I once heard Dolly Parton describe how she and her 11 siblings took baths…   Read more»

Posted by: @pv223 In this week’s lecture we learned about different aspects of monitoring and controlling a project and how anything can really be subject to change throughout the life cycle. Assume you are a project manager and you are…   Read more»

When I think about one of the projects that I worked on and risk, I immediately think about a building project where there were so many moving parts- the greatest “risk” was not opening on time, and on time means…   Read more»

Posted by: @sallirab When we say the word “Risk” it always come in mind a Negative thoughts, but does the Risk are always negative ? As we know Risk results can be positive or negative, can you please give an…   Read more»

The most significant part, in my opinion, is customer input. If the customer’s wants aren’t recognized from the start, the entire design control process could be squandered by focusing on components that aren’t part of the customer’s picture of the…   Read more»

I never gave the difference between validation and verification much thought. After doing so, verification is the process of ensuring that your product complies with the specifications and requirements you’ve written. “Did I build what I promised? Validation tests are…   Read more»

I am a huge fan of meeting minutes! I note these during all of my team meetings and 1 on 1s with my manager. This helps me stay organized and remember what was previously discussed. It is also important for…   Read more»

The difference in communication when working from home. I believe most individuals would agree that effective communication between the project manager and the project team is of paramount importance.  Before the pandemic, being able to work from home was a…   Read more»